Tetra Bio-Pharma (TSXV: TBP) has received a much anticipated response from the US Food and Drug Administration (FDA) regarding the status of its Caumz product. Following the Type B meeting held between that of the FDA and Tetra Bio Pharma, the company has been approved to apply for a fast track designation for the product.
Tetra’s clinical data to date has enabled management to assess that the Caumz product should make an impact on the survival of cancer patients and positively improve their day to day functioning. The product provides a currently unmet medical need, and thus qualifies for the fast track and expidited review program.
Upon submitting the required documentation for a fast track designation request, the FDA is expected to respond within sixty days of filing. Overall review time as a result of the designation is expected to be reduced from an average of ten months to that of six months. Frequent communication is also a feature of the process, which is expected to further reduce any delay in getting the product approved and on to the market.
Further, Tetra successfully made the case that Caumz should also qualify for accelerated approval, which the FDA was in agreeance with. The qualification for this is based on products “that are developed for the treatment of serious conditions in which the use of a surrogate endpoint is justified because the measured clinical benefit takes a long time to measure.” Due to Caumz being a product intended for “cancer cachexia patients with an advanced, incurable and malignant cancer that is refractory to treatment,” and is intended to improve survival and day to day functioning, the product was approval for the accelerated approval process.
A drug has not been previously approved for the specific intended use by the Food and Drug Administration, and as such the organization will be providing detailed guidance on the development program. The guidance as a result enables Caumz to be differentiated from that of Qixleef, avoiding direct competition between Tetra’s own products.
Tetra Bio Pharma last traded at $0.51 on the TSX Venture.
Information for this briefing was found via Sedar and Tetra Bio-Pharma Inc. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
